Fetal Heart Rate Monitor

Diagnostic/Prevention

• 

  Representative Product

  Condition
  Fetal heart rate (FHR) is monitored to detect variations that may indicate a distressed fetus. Variations in FHR may signal complications including intrauterine hypoxia, placental abruption, uterine rupture, or constriction of the umbilical cord.

   

  Mechanism of Action
  Electronic fetal monitoring (EFM), doppler ultrasound, and Pinard stethoscopes are all commonly used to assess FHR. EFM provides continuous monitoring either using a doppler sensor on the mother’s abdomen or a fetal scalp electrode. Doppler devices use a handheld ultrasonic transducer (coupled to the mother’s abdomen with a gel), to transmit and detect reflected 2-3MHz sound waves from the moving fetal heart. Many devices provide a digital read out; virtually all provide an audible representation of the heart beat.

   

  Pinard stethoscopes are simple plastic or metal cones used to ausculate the FHR directly. By placing the larger opening firmly on the mother’s abdomen, the user can listen for the baby’s heartbeat from the smaller end.  The electronic methods can detect FHR after about 10 weeks gestation; the Pinard after approximately 20 weeks.

   

  Current Use in High-Resource Settings 
  Electronic fetal monitoring is used in approximately 85% of all US births, providing a continuous record of FHR throughout labor and delivery. Use of EFM is associated with increased cesarean section and instrumental delivery, but not necessarily improved perinatal outcomes relative to intermittent auscultation with Doppler ultrasound. Prior to delivery, Doppler is commonly used at each prenatal appointment after 10 weeks.

   

  Application in Low-Resource Settings 
  Pinard stethoscopes are the most common method of monitoring FHR in low-resource settings. They do not require power, are highly portable, and typically cost around $2. Doppler devices have been associated with more favorable outcomes, more reliable measurement, and greater patient and caregiver comfort. Cost remains an issue for the penetration of these devices, although when available, their utilization and efficacy appear to be satisfactory. Furthermore, many births in low-resource settings are not done at a clinic or with a skilled birth attendant who is able to intervene if there is a non-reassuring heart rate.

   

  Associated Technologies in Development

  ACT for Birth, Maternal-Fetal Monitoring system

  REPRESENTATIVE DEVICES

  MAKE

  MODEL

  PRICE

  TECH

  STATUS

  NOTES

  Freeplay

  FHRM

  $300

  Doppler

  Piloted

  Hand cranked device, no battery required

  Huntleigh

  Sonicaid FD1

  $600-700

  Doppler

  Marketed

  Digital readout and waterproof probe

  HiBebe

  BT-200

  $100

  Doppler

  Marketed

  Digital readout plus audio

  AngelSounds

  JPD 100S

  $25-50

  Doppler

  Marketed

  Consumer product, audio only

  Generic

  Pinard

  $2

  Pinard

  Marketed

  Highly portable, accuracy subject to user skill

  * Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

• CHARACTERISTICS OF REPRESENTATIVE PRODUCT

  Technology Characteristics

  Operational Parameters

  Potential opportunities for improvement

  SKILLS

  REQUIRED

  Intended end user

  Training required

  Time required per use

  Physician, Nurse

  Hours

  Minutes

  Training may be required to translate the numerical FHR and FHR trend over time into an action plan to improve the outcome of pregnancy.

  ENVIRONMENT/ INFRASTRUCTURE

  Power required

  Waste collection

  Complementary technologies required

  Temperature and storage

  Maintenance

  Two 1.5V batteries

  None

  Coupling gel

  N/A

  N/A

  Battery supply has been a problem for this class of device. While the Freeplay FHRM operates without batteries (using a crank mechanism) the incremental $200 in price may still be too high for wide deployment.

  COST

  Product Cost (Approx)

  Cost/use (Approx)

  $100

  <$0.10

  Doppler will never be price competitive with the $2 Pinard stethoscope, but most caregivers prefer the comfort and accuracy of doppler.

  OTHER

  Portability

  Regulatory

  Efficacy

  <500g

  FDA and CE approved

  Intermittent auscultation with fetal doppler has been shown to have similar outcomes to continuous EFM

  Additional devices required for impact: Instrumental delivery, cesarean section, or other interventions may be required depending on the severity of FHR abnormalities.